Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus ≥ 10 g/dL: an exploratory analysis of a phase 3 trial.
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Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus ≥ 10 g/dL: an exploratory analysis of a phase 3 trial. / Canon, Jean-Luc; Vansteenkiste, Johan; Hedenus, Michael; Gascon, Pere; Bokemeyer, Carsten; Ludwig, Heinz; Vermorken, Jan; Legg, Jason; Pujol, Beatriz; Bridges, Ken.
In: MED ONCOL, Vol. 29, No. 3, 3, 2012, p. 2291-2299.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus ≥ 10 g/dL: an exploratory analysis of a phase 3 trial.
AU - Canon, Jean-Luc
AU - Vansteenkiste, Johan
AU - Hedenus, Michael
AU - Gascon, Pere
AU - Bokemeyer, Carsten
AU - Ludwig, Heinz
AU - Vermorken, Jan
AU - Legg, Jason
AU - Pujol, Beatriz
AU - Bridges, Ken
PY - 2012
Y1 - 2012
N2 - Darbepoetin alfa (DA) is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anemia (CIA). Safety concerns have prompted changes to the ESA-product information, which now recommends initiating ESAs at hemoglobin (Hb) levels < 10 g/dL (US) or ? 10 g/dL (EU). The present exploratory analysis of a DA trial examined how baseline-Hb levels at ESA initiation affect transfusion rates, Hb response, and safety outcomes in CIA patients. Data were retrospectively analyzed from a phase 3 trial of CIA patients randomised to 500 mcg DA every 3 weeks (Q3 W) or to 2.25 mcg/kg DA weekly (QW) for 15 weeks. In the current analysis, data were reanalyzed by baseline-Hb categories of <9 g/dL (n = 126), 9 to <10 g/dL (n = 225), and ? 10 g/dL (n = 354). The Q3 W and QW groups were combined. Transfusion rates were highest in the <9 g/dL baseline-Hb group in all time periods examined. The Kaplan-Meier percentage (95% CI) of patients achieving Hb ? 10 g/dL was 68% (59, 78) and 88% (82, 92) in the <9 g/dL and 9 to <10 g/dL baseline-Hb groups, respectively. With lower baseline-Hb, incidence of a ? 1 g/dL-Hb rise in 14 days progressively decreased. Incidence of venous thromboembolic events was similar in all baseline-Hb groups and similar between patients with or without a ? 1 g/dL-Hb rise in 14 days. Overall, transfusion risk increased and Hb response decreased at lower baseline-Hb levels in this exploratory analysis. When following ESA-product information to initiate ESAs at Hb ? 10 g/dL, the greatest benefit may be achieved when initiating close to 10 g/dL. Prospective studies are needed to further examine this hypothesis.
AB - Darbepoetin alfa (DA) is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anemia (CIA). Safety concerns have prompted changes to the ESA-product information, which now recommends initiating ESAs at hemoglobin (Hb) levels < 10 g/dL (US) or ? 10 g/dL (EU). The present exploratory analysis of a DA trial examined how baseline-Hb levels at ESA initiation affect transfusion rates, Hb response, and safety outcomes in CIA patients. Data were retrospectively analyzed from a phase 3 trial of CIA patients randomised to 500 mcg DA every 3 weeks (Q3 W) or to 2.25 mcg/kg DA weekly (QW) for 15 weeks. In the current analysis, data were reanalyzed by baseline-Hb categories of <9 g/dL (n = 126), 9 to <10 g/dL (n = 225), and ? 10 g/dL (n = 354). The Q3 W and QW groups were combined. Transfusion rates were highest in the <9 g/dL baseline-Hb group in all time periods examined. The Kaplan-Meier percentage (95% CI) of patients achieving Hb ? 10 g/dL was 68% (59, 78) and 88% (82, 92) in the <9 g/dL and 9 to <10 g/dL baseline-Hb groups, respectively. With lower baseline-Hb, incidence of a ? 1 g/dL-Hb rise in 14 days progressively decreased. Incidence of venous thromboembolic events was similar in all baseline-Hb groups and similar between patients with or without a ? 1 g/dL-Hb rise in 14 days. Overall, transfusion risk increased and Hb response decreased at lower baseline-Hb levels in this exploratory analysis. When following ESA-product information to initiate ESAs at Hb ? 10 g/dL, the greatest benefit may be achieved when initiating close to 10 g/dL. Prospective studies are needed to further examine this hypothesis.
KW - Adult
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - Young Adult
KW - Double-Blind Method
KW - Risk
KW - Anemia/chemically induced/drug therapy
KW - Antineoplastic Agents/adverse effects
KW - Blood Transfusion
KW - Erythropoietin/administration & dosage/adverse effects/analogs & derivatives
KW - Hematinics/administration & dosage/adverse effects
KW - Hemoglobins/analysis
KW - Neoplasms/drug therapy
KW - Adult
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - Young Adult
KW - Double-Blind Method
KW - Risk
KW - Anemia/chemically induced/drug therapy
KW - Antineoplastic Agents/adverse effects
KW - Blood Transfusion
KW - Erythropoietin/administration & dosage/adverse effects/analogs & derivatives
KW - Hematinics/administration & dosage/adverse effects
KW - Hemoglobins/analysis
KW - Neoplasms/drug therapy
M3 - SCORING: Journal article
VL - 29
SP - 2291
EP - 2299
JO - MED ONCOL
JF - MED ONCOL
SN - 1357-0560
IS - 3
M1 - 3
ER -
